- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816034
Cerebellar Alterations in Individuals With a Cannabis Use Disorder
November 1, 2018 updated by: Paul Verschure, Universitat Pompeu Fabra
Alterations in Cerebellar-dependent Adaptation Due to Cannabis Use Measured With an Explicit-implicit Visuo-motor Learning Paradigm
The purpose of this study is to investigate if individuals with a cannabis use disorder have an impaired cerebellar function by assessing possible alterations to their implicit adaptation during a visuomotor rotation task.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed with a Cannabis use disorder following Diagnostic and Statistical Manual (DSM-V) criteria.
- Patients screen positive to cannabis in the urine analysis performed a week prior to assessment.
- Right-handed patients.
- Patients provide a signed consent.
Exclusion Criteria:
- Patients with another current substance use disorder (with the exception of tobacco).
- Patients with a visual impairment that has not been corrected.
- Patients with a cognitive impairment such as mental retardation.
- Patients with psychotic disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Explicit
Cannabis user performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance
|
Participant moves a cursor on a screen by sliding a pen over a digital tablet.
Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed.
In several block of trials, the mapping of the pen position to the cursor is rotated.
Participant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target
|
ACTIVE_COMPARATOR: Control Explicit
Healthy subject performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance
|
Participant moves a cursor on a screen by sliding a pen over a digital tablet.
Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed.
In several block of trials, the mapping of the pen position to the cursor is rotated.
|
EXPERIMENTAL: Experimental Implicit
Cannabis user performs visuo-motor rotation tasks without being informed of the explicit strategy
|
Participant moves a cursor on a screen by sliding a pen over a digital tablet.
Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed.
In several block of trials, the mapping of the pen position to the cursor is rotated.
Participant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target
|
ACTIVE_COMPARATOR: Control Implicit
Healthy subject performs visuo-motor rotation tasks without being informed of the explicit strategy
|
Participant moves a cursor on a screen by sliding a pen over a digital tablet.
Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed.
In several block of trials, the mapping of the pen position to the cursor is rotated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Directional error of hand trajectories towards a target
Time Frame: 1 day (a single session)
|
1 day (a single session)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reaction times
Time Frame: 1 day (a single session)
|
1 day (a single session)
|
Intrinsic Motivational Inventory
Time Frame: 1 day (a single session)
|
1 day (a single session)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Taylor JA, Klemfuss NM, Ivry RB. An explicit strategy prevails when the cerebellum fails to compute movement errors. Cerebellum. 2010 Dec;9(4):580-6. doi: 10.1007/s12311-010-0201-x.
- Mazzoni P, Krakauer JW. An implicit plan overrides an explicit strategy during visuomotor adaptation. J Neurosci. 2006 Apr 5;26(14):3642-5. doi: 10.1523/JNEUROSCI.5317-05.2006.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2016
Primary Completion (ACTUAL)
April 1, 2017
Study Completion (ACTUAL)
April 1, 2017
Study Registration Dates
First Submitted
June 6, 2016
First Submitted That Met QC Criteria
June 27, 2016
First Posted (ESTIMATE)
June 28, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 5, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CannabinoidsCerebellum
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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